Guercetti Julian, Alorda Marc, Sappia Luciano, Galve Roger, Duran-Corbera Macarena, Pulido Daniel, Berardi Ginevra, Royo Miriam, Lacoma Alicia, Muñoz José, Padilla Eduardo, Castañeda Silvia, Sendra Elena, Horcajada Juan P, Gutierrez-Galvez Agustín, Marco Santiago, Salvador J-Pablo, Marco M-Pilar
Nanobiotechnology for Diagnostics Group, Instituto de Química Avanzada de Cataluña, IQAC-CSIC, C/Jordi Girona 18-26, 08034 Barcelona, Spain.
CIBER de Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN), Instituto de Salud Carlos III, 28029 Madrid, Spain.
ACS Pharmacol Transl Sci. 2025 Feb 21;8(3):871-884. doi: 10.1021/acsptsci.4c00727. eCollection 2025 Mar 14.
A multiplexed microarray chip (-μSARS2) aiming at providing information on the prognosis of the COVID-19 has been developed. The diagnostic technology records information related to the profile of the immunological response of patients infected by the SARS-CoV-2 virus. The diagnostic technology delivers information on the avidity of the sera against 28 different peptide epitopes and 7 proteins printed on a 25 mm area of a glass slide. The peptide epitopes (12-15 mer) derived from structural proteins (Spike and Nucleocapsid) have been rationally designed, synthesized, and used to develop -μSARS2 as a multiplexed and high-throughput fluorescent microarray platform. The analysis of 755 human serum samples (321 from PCR+ patients; 288 from PCR- patients; 115 from prepandemic individuals and classified as hospitalized, admitted to intensive-care unit (ICU), and ) from three independent cohorts has shown that the chips perform with a 98% specificity and 91% sensitivity identifying RT-PCR+ patients. Computational analysis utilized to correlate the immunological signatures of the samples analyzed indicate significant prediction rates against conditions with 82% accuracy, ICU admissions with 80% accuracy, and 73% accuracy over hospitalization requirement compared to asymptomatic patients' fingerprints. The miniaturized microarray chip allows simultaneous determination of 96 samples (24 samples/slide) in 90 min and requires only 10 μL of sera. The diagnostic approach presented for the first time here could have a great value in assisting clinicians in decision-making based on the information provided by the -μSARS2 regarding progression of the disease and could be easily implemented in diagnostics of other infectious diseases.
一种旨在提供新冠病毒疾病预后信息的多重微阵列芯片（-μSARS2）已被开发出来。该诊断技术记录了感染严重急性呼吸综合征冠状病毒2（SARS-CoV-2）病毒患者的免疫反应特征相关信息。该诊断技术可提供有关血清针对印在25毫米玻片区域上的28种不同肽表位和7种蛋白质的亲和力信息。源自结构蛋白（刺突蛋白和核衣壳蛋白）的肽表位（12 - 15聚体）经过合理设计、合成，并用于开发-μSARS2作为多重高通量荧光微阵列平台。对来自三个独立队列的755份人类血清样本（321份来自PCR检测呈阳性患者；288份来自PCR检测呈阴性患者；115份来自疫情前个体，并分为住院患者、重症监护病房（ICU）收治患者等）的分析表明，这些芯片在识别RT-PCR检测呈阳性患者时，特异性为98%，灵敏度为91%。用于关联所分析样本免疫特征的计算分析表明，针对病情状况的预测准确率为82%，针对ICU收治情况的预测准确率为80%，与无症状患者指纹相比，针对住院需求的预测准确率为73%。这种小型化微阵列芯片能够在90分钟内同时检测96个样本（每张玻片24个样本），且仅需10微升血清。此处首次提出的诊断方法对于协助临床医生根据-μSARS2提供的有关疾病进展信息进行决策可能具有重要价值，并且能够很容易地应用于其他传染病的诊断。
